Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,6R)-4,6-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,6R)-4,6-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
EC number: 700-927-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed equivalent or similar to OECD 404 guideline, but predating GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observations were not continued until day 14 to detemine the reversibility of the effects.
- GLP compliance:
- no
- Remarks:
- Study performed around/just before the time GLP was introduced in Europe, but internal QA statement.
Test material
- Reference substance name:
- Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
- EC Number:
- 700-927-7
- Molecular formula:
- C17H30O2
- IUPAC Name:
- Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): PM 968
- Physical state: liquid
- Description: clear, colourless solution
- Storage condition of test material: no data available.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: commercial supplier
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Housing: individually
- Diet: free access to pelleted food
- Water: free access to water
- Acclimation period: no data available
ENVIRONMENTAL CONDITIONS
- No data available.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin of each animal serves as its own control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 8
- Details on study design:
- STUDY DESIGN
The test is designed to investigate the irritant effects of a single application of a substance under semi-occlusive conditions. A standard substance (Geraniol) was applied for comparative purposes; no untreated control animals are used. The untreated skin of each animal serves as its own control.
TEST SITE
Three to four days prior to testing, the dorsal areas of the trunks of the animals were clipped to identify those which are in telogen (non-growth phase of the hair cycle) and which have no skin blemishes. Of these suitable rabbits, at least three and normally eight are selected for the test. A final clipping of the test animals is made approximately 24 hours before testing.
The test substance was applied to the skin of one flank, using a gauze patch of 25x25 mm.
REMOVAL OF TEST SUBSTANCE
Four hours after the application, the patches were removed and excess substance wiped from the skin with a damp tissue.
OBSERVATIONS
- Irritation: The animals were observed for signs of erythema and oedema and the response graded at 30 to 60 minutes, and then at 24, 48 and 72 hours after patch removal.
SCORING SYSTEM:
Dermal irritation is graded and recorded according to the system described in OECD 404. Further observations may be needed, as necessary, to establish reversibility. In addition to the observation of irritation, any serious lesions such as corrosion (irreversible destruction of skin tissue) and other
toxic effects are fully described.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #7
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal: #2 and #8
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal: #4, #5 and #6
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #3, #5 and #8
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #4 and #7
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- no data
- Irritant / corrosive response data:
- The substance showed very slight to well-defined erythema 72 hours after patch removal in 7 animals. In one animal erythema was fully reversible within 72 hours.
The substance showed very slight oedema 72 hours after patch removal in 3 animals. In 4 animals oedema was fully reversible within 48 hours and in 1 animal the irritation effects were fully reversible within 72 hours.
No data is available after 72 hours. 7 animals still had very slight erythema, in addition 3 of these still had very slight oedema.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was tested in a skin irritation test in rabbits equivalent or similar to OECD 404 guideline and GLP principles. The substance is considered to be not irritating.
- Executive summary:
The substance was tested in a skin irritation test in rabbits equivalent or similar to OECD 404 guideline and GLP principles.
The substance showed very slight to well-defined erythema 72 hours after patch removal in 7 animals. In one animal the erythema effects were fully reversible within 72 hours. In addition, the substance showed very slight oedema 72 hours after patch removal in 3 animals. In 4 animals the oedema was fully reversible within 48 hours and in 1 animal the erythema was fully reversible within 72 hours though observations were not continued until day 14 to detemine the reversibility of the effects. The scores averaged over 3 days do not indicate skin irritation and in several animals the effects were reversible within 72 hours. Therefore, the substance is not considered to be irritating to skin. In addition, the substance has no reactive functional groups and it also has a high log Kow limiting dermal absorption and this absorption is needed for skin irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.